NCT06710847

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Solid tumours are abnormal lumps of tissue that can occur in different parts of the body. The tumours involved in this study have specific genetic characteristics that can make them more aggressive and challenging to treat. The study will test whether GSK4418959 alone or in combination with a PD-1 inhibitor agent can decrease tumor size, is safe, well-tolerated, and how amounts of the study drug decrease in the body over time.

Conditions

• Neoplasms, Colorectal
• Solid Tumor
• Colon Cancer
• Rectal Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	GSK4418959	GSK4418959 will be administered.
BIOLOGICAL	PD-1 inhibitor	PD-1 inhibitor will be administered.

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-06-22
• Completion: 2026-06-22
• First posted: 2024-11-29
• Last updated: 2026-02-02

Locations

22 sites across 7 countries: United States, Australia, Belgium, Japan, Netherlands, South Korea, Spain

Regulatory

• FDA-regulated drug study